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Cromolyn Sodium eent

Pronunciation

Class: Antiallergic Agents
VA Class: RE100
CAS Number: 15826-37-6
Brands: Crolom, Nasalcrom

Introduction

Mast-cell stabilizer.208 215 b

Uses for Cromolyn Sodium

Allergic Rhinitis

Self-medication for the symptomatic prevention and treatment of seasonal or perennial allergic rhinitis.204 Provides symptomatic relief of rhinorrhea, nasal congestion, sneezing, and postnasal drip.a

Should not use as self-medication for the treatment of sinus infection, asthma, or cold symptoms.204

Allergic Ocular Disorders

Symptomatic treatment of certain allergic ocular disorders (e.g., vernal keratoconjunctivitis,205 208 213 vernal conjunctivitis,205 208 213 vernal keratitis).205 208 213 b

Has been used for the treatment of giant papillary conjunctivitis.207

Cromolyn Sodium Dosage and Administration

General

  • For patients with seasonal or perennial rhinitis, continue therapy throughout the period of allergen exposure (e.g., until the pollen season is over or contact with allergen has ceased).215

  • If exposure to allergens cannot be predicted, initiate therapy at the first sign of nasal symptoms.215

  • Should not use other ocular agents with ophthalmic solution unless directed by a clinician.206 209 216 However, may use corticosteroids with ophthalmic solution.205

Administration

Administer intranasally or topically to the eye.204 205 206

Administer at regular intervals.204 205 206

Intranasal Administration

Parents or care providers must supervise use by young children.204 In very young children, an adult should administer nasal solution.215 Use care when inserting the nozzle into the nose to avoid injury.215

Prior to administration, clear nasal passages by blowing the nose;215 administration of a topical nasal decongestant may be necessary.a Inhale through the nose during administration.215

For maximum therapeutic effect, initiate therapy before (e.g., ≤1–2 weeks before) and continue at regular intervals during the period of allergen exposure.204 215

Ophthalmic Administration

Applied topically to the eye as an ophthalmic solution just inside the lower eyelid; patients should avoid applying the solution directly on the cornea.205 206 209 216

To avoid contamination of dropper tip and solution, avoid touching the tip of the dispensing dropper or container to the eye, fingers, or any other surface.206 209 216

Dosage

Available as cromolyn sodium.204 205

Nasal pump delivers 5.2 mg of cromolyn sodium per metered spray.204

One drop of cromolyn sodium ophthalmic solution contains approximately 1.6 mg of cromolyn sodium.205 b

Pediatric Patients

Allergic Rhinitis
Intranasal

Children ≥2 years of age: 1 spray (5.2 mg) in each nostril 3 or 4 times daily given at regular intervals (morning, noon, dinner, bedtime)215 for ≤12 weeks.204 215 When necessary, may be used up to 6 times daily.204 215

Allergic Ocular Disorders
Ophthalmic

Children ≥4 years of age: 1 or 2 drops in each eye 4–6 times daily at regular intervals.205 208 213 b

Do not exceed recommended frequency of administration.205 208 213 b

Adults

Allergic Rhinitis
Intranasal

1 spray (5.2 mg) in each nostril 3 or 4 times daily (morning, noon, dinner, bedtime)215 for ≤12 weeks.204 215 When necessary, may be used up to 6 times daily.204 215

Allergic Ocular Disorders
Ophthalmic

1 or 2 drops in each eye 4–6 times daily at regular intervals.205 208 213 b

Cautions for Cromolyn Sodium

Contraindications

  • Known hypersensitivity to cromolyn sodium or any ingredient in the formulations.204 205 213

Warnings/Precautions

Warnings

General Precautions

Ocular Effects

Ophthalmic solution: Transient stinging or burning sensation may occur.205 208 213 b

Respiratory Effects

Nasal solution: Transient nasal stinging and/or sneezing may occur immediately.204 215 Discontinue drug if nasal irritation occurs.215

Specific Populations

Pregnancy

Category B.205 208 213 b

Lactation

Not known whether cromolyn is distributed into milk.205 b Use ophthalmic solution with caution.205 208 213 b With nasal spray, consult a clinician prior to use.204

Pediatric Use

Safety and efficacy of cromolyn sodium given as the nasal solution204 or ophthalmic solution205 213 b not established in children <2 or <4 years of age, respectively.

Geriatric Use

Ophthalmic solution: No differences in safety or efficacy relative to younger adults.208 213

Common Adverse Effects

Nasal solution: Nasal burning and stinging, nasal irritation, sneezing.204 215 a

Ophthalmic solution: Transient ocular stinging or burning upon instillation.205 208 213

Cromolyn Sodium Pharmacokinetics

Absorption

Bioavailability

Approximately <7 or 0.03% absorbed following an intranasal dosea or an ophthalmic dose, respectively.205 213 b

Onset

Nasal solution: Improvement may take several days; best effect not seen for 1–2 weeks.204 215

Ophthalmic solution: Improvement usually noted in a few days; treatment for up to 6 weeks sometimes needed to see improvement.205 208 213 b

Distribution

Extent

Does not cross most biologic membranes well.a

Minimally crosses the placenta (<0.1%) and minimally distributed into milk (<0.001% of a dose) in animals.a

Elimination

Half-life

81 minutes.a

Stability

Storage

Intranasal

Nasal Solution

20–25°C; protect from light.204 215

Ophthalmic

Ophthalmic Solution

20–25°C or 15–30°C, depending on manufacturer; protect from light.205 206 208 209 213 216 b Store in original carton.b

Actions

  • Acts mainly through a local effect on the nasal mucosa or eyes.a 215

  • Inhibits degranulation of sensitized mast cells that occurs after exposure to specific antigens.205 213 b Inhibits release of mediators of type I allergic reactions, including histamine and cysteinyl leukotrienes (slow-reacting substance of anaphylaxis [SRS-A])214 from sensitized mast cells.3 5 6 10 12 33 205 208 212 213 Inhibits phospholipase A-induced mast cell degranulation and subsequent release of chemical mediators in vitro.205 208 b

  • No direct antihistamine, anticholinergic, antiserotonin, anti-inflammatory, vasoconstrictor, or corticosteroid-like properties.a b 205 213

Advice to Patients

  • Importance of providing patient a copy of manufacturer’s patient information.204

  • Importance of clinicians instructing patients about proper use, including proper administration of the particular dosage form employed.205 208 213

  • With nasal solution, importance of informing a clinician of symptoms such as fever, discolored nasal discharge, sinus pain, or wheezing prior to use.204

  • Importance of administration of drug at regular intervals.205 208 213 215 b

  • Importance of avoiding exposure to allergens.215

  • Importance of advising patients with seasonal or perennial allergic rhinitis to begin therapy before (e.g., ≤1–2 weeks before), and to continue therapy at regular intervals during, the period of allergen exposure.204 215

  • With intranasal cromolyn, importance of advising patients with allergic rhinitis to discontinue therapy and consult a clinician if symptoms worsen, new symptoms occur, symptoms do not begin to improve within 2 weeks of treatment initiation, or if treatment is required for longer than >12 weeks.204 215

  • Importance of discontinuing drug and contacting a clinician if shortness of breath, wheezing, hives or swelling of the mouth or throat, or chest tightness occurs.204 215

  • Importance of not wearing contact lenses during treatment with cromolyn ophthalmic solution.205 206 208 209 213 216

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.204

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.205

  • Importance of informing patients of other important precautionary information.205 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Cromolyn Sodium

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Nasal

Solution

5.2 mg/metered spray*

Cromolyn Sodium Nasal Spray (with benzalkonium chloride 0.01% and edetate disodium 0.1%)

Actavis, Bausch & Lomb, Perrigo

Nasalcrom (with benzalkonium chloride 0.01% and edetate disodium 0.1%)

Pfizer

Ophthalmic

Solution

4%

Crolom (with benzalkonium chloride 0.01% and edetate disodium 0.1%)

Bausch & Lomb

Cromolyn Sodium Ophthalmic Solution (with benzalkonium chloride 0.01% and edetate disodium 0.1%)

Akorn, Alcon, King, Novex, Pacific Pharma

AHFS DI Essentials. © Copyright 2016, Selected Revisions July 1, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

3. Cox JS. Disodium cromoglycate: a specific inhibitor of reaginic antibody-antigen mechanisms. Nature. 1967; 216:1328-9. [PubMed 6080064]

5. Anon. Disodium cromoglycate. Lancet. 1972; 2:1299.

6. Anon. Disodium cromoglycate in allergic respiratory disease. Br Med J. 1972; 2:159-61.

10. Falliers CJ. Cromolyn sodium. J Allergy. 1971; 47:298-305. [PubMed 4104162]

12. Orr TS, Cox JS. Disodium cromoglycate, an inhibitor of mast cell degranulation and histamine release induced by phospholipase A. Nature. 1969; 223: 197. [PubMed 4183038]

33. Sheard P, Blair AM. Disodium cromoglycate activity in three in vitro models of immediate hypersensitivity reaction in the lung.Int Arch Allergy Appl Immunol. 1970; 217-24.

204. Pfizer Consumer Healthcare. Nasalcrom(cromolyn sodium) nasal spray product description. Morris Plains, NJ; 2006.

205. Akorn. Cromolyn sodium ophthalmic solution USP 4% prescribing information. Somerset, NJ; 1999 May.

206. Akorn. Cromolyn sodium ophthalmic solution USP 4% information for the patient. Somerset, NJ; 1999 May.

207. Fisons. Opticrom 4% (cromolyn sodium) ophthalmic solution prescribing information. Bedford, MA; 1985 Nov.

208. Pacific Pharma. Cromolyn sodium ophthalmic solution USP, 4% prescribing information. Irvine, CA; 2004 Sep.

209. Pacific Pharma. Cromolyn sodium ophthalmic solution USP, 4% information for the patient. Irvine, CA; 2004 Sep.

212. National Institutes of Health, National Heart, Lung, and Blood Institute. Global initiative for asthma: global strategy for asthma management and prevention NHLBI/WHO Workshop Report. Bethesda, MD: National Institutes of Health. 2005 Oct. NIH/NHLBI Publication No. 02-3659. Available at: . Accessed Nov 7, 2006.

213. Bausch & Lomb. Crolom (cromolyn sodium) ophthalmic solution USP 4% prescribing information. Tampa, FL; 2004 Jan.

214. Drazen JM, Israel E, O'Byrne PM. Treatment of asthma with drugs modifying the leukotriene pathway. N Engl J Med. 1999; 340:197-206. [IDIS 418266] [PubMed 9895400]

215. Bausch & Lomb. Cromolyn sodium nasal solution USP patient information. Tampa, FL. Undated.

216. Bausch & Lomb. Crolom (cromolyn sodium) ophthalmic solution USP 4% information for the patient. Tampa, FL; 2004 Jan.

a. AHFS drug information 2007. McEvoy GK, ed. Cromolyn Sodium. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2776-2777.

b. King Pharmaceuticals. Cromolyn sodium ophthalmic solution prescribing information. Bristol, TN; 1999 May.

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